Apparatus and method for suturing body lumens

ABSTRACT

An apparatus for suturing body lumens is provided. The apparatus includes a flexible elongated member that has a proximal end, a distal end, a central passage and multiple needle lumens extending from the proximal end toward the distal end. The flexible elongated member further includes an elongated subsection spanning from the end of the needle lumens in the elongated member to a barrel portion that includes corresponding needle lumens on the proximal end of the elongated member. The elongated subsection provides sufficient space between the needles and the barrel portion to allow transapical insertion of the elongated member into a body lumen. The apparatus further includes needles disposed within and advancable from the needle lumens. The apparatus also includes a handle disposed at the proximal end of the elongated member. The handle is operable to retract the needles through the needle lumens toward the handle at the proximal end.

BACKGROUND

1. Technical Field

The present disclosure relates generally to techniques and devices forclosing openings in body lumens. More particularly, the presentdisclosure relates to systems, devices, and methods for percutaneousclosure of arterial and venous puncture sites, which are usuallyaccessed through a tissue tract.

2. The Relevant Technology

Many diagnostic and interventional vascular procedures are now performedtranslumenally. A catheter is introduced to the vascular system at aconvenient access location and guided through the vascular system to atarget location using established techniques. Such procedures requirevascular access, which is usually established using the well-knownSeldinger technique. Vascular access is generally provided through anintroducer sheath, which is positioned to extend from outside thepatient's body into the vascular lumen. When vascular access is nolonger required, the introducer sheath is removed and bleeding at thepuncture site is stopped using one of a variety of methods.

One method for providing hemostasis (the cessation of bleeding) is toapply external force near and upstream from the puncture site, typicallyby manual compression. This approach suffers from a number ofdisadvantages. For example, the manual compression procedure is timeconsuming, frequently requiring 30 or more minutes of compression beforehemostasis is achieved. Additionally, such compression techniques relyon clot formation, which can be delayed until anticoagulants used invascular therapy procedures (such as for heart attacks, stentdeployment, non-optical PTCA results, and the like) wear off. Theanticoagulants may take two to four hours to wear off, therebyincreasing the time required before completion of the manual compressionprocedure.

Further, the manual compression procedure is uncomfortable for thepatient and frequently requires analgesics to be tolerable. Moreover,the application of excessive pressure can at times totally occlude theunderlying blood vessel, resulting in ischemia and/or thrombosis.Following manual compression, the patient typically remains recumbentfrom four to twelve hours or more under close observation to assurecontinued hemostasis. During this time, renewed bleeding may occur,resulting in blood loss through the tract, hematoma and/orpseudo-aneurysm formation, as well as arteriovenous fistula formation.These complications may require blood transfusions and/or surgicalintervention.

The incidence of complications from the manual compression procedureincreases when the size of the introducer sheath grows larger, and/orwhen the patient is anticoagulated. The compression technique forarterial closure can be risky, and is expensive and onerous to thepatient. Although using highly trained individuals can reduce the riskof complications, dedicating such personnel to this task is bothexpensive and inefficient. Nonetheless, as the number and efficacy oftranslumenally performed diagnostic and interventional vascularprocedures increases, the number of patients requiring effectivehemostasis for a vascular puncture continues to increase.

To overcome the problems associated with manual compression,bioabsorbable sealing bodies have been used. Generally, a thrombogenicand bioabsorbable material, such as collagen, is placed at thesuperficial wall of the body lumen over the puncture site. Whilepotentially effective, this approach suffers from a number of drawbacks.For example, bioabsorbable sealing bodies may lack a solid mechanicalattachment of the sealing body to the tissue. Due to the lack of a solidmechanical attachment, the sealing body can wander within the tissuetract or move out of the puncture site, thus causing late bleeds.Conversely, if the sealing body wanders and intrudes too far into thebody lumen, due to the lack of a solid mechanical attachment,intravascular clots and/or collagen pieces with thrombus attached canform and embolize downstream, causing vascular occlusion.

BRIEF SUMMARY

This Summary is provided to introduce a selection of concepts in asimplified form that are further described below in the DetailedDescription. This Summary is not intended to identify key features oressential features of the claimed subject matter, nor is it intended tobe used as an aid in determining the scope of the claimed subjectmatter. Embodiments described herein provide systems, methods, anddevices for closing an opening in tissue. Embodiments can be configuredto close an opening within a body lumen.

For instance, in one embodiment, an apparatus for suturing a body lumenincludes a flexible elongated member that has a proximal end, a distalend, a central passage and multiple needle lumens extending from theproximal end toward the distal end. The flexible elongated memberfurther includes an elongated subsection spanning from the end of theneedle lumens in the elongated member to a barrel portion that includescorresponding needle lumens on the proximal end of the elongated member.The elongated subsection provides sufficient space between the needlesand the barrel portion to allow transapical insertion of the elongatedmember into a body lumen. The apparatus further includes multipledifferent needles disposed within and advancable from the needle lumensin the flexible elongated member across the elongated subsection tocorresponding needle lumens in the barrel portion. The apparatus alsoincludes a handle disposed at the proximal end of the elongated member.The handle is operable to retract the needles through the needle lumensof the elongated member across the elongated subsection toward thehandle at the proximal end.

In another embodiment, a method is provided for suturing an opening in abody lumen. The method includes providing a body lumen suturing device,where the body lumen suturing device includes a flexible elongatedmember that has a proximal end, a distal end, a central passage andmultiple needle lumens extending from the proximal end toward the distalend. The flexible elongated member includes an elongated subsectionspanning from the end of the needle lumens in the elongated member to abarrel portion that includes corresponding needle lumens on the proximalend of the elongated member. The elongated subsection providessufficient space between the needles and the barrel portion to allowtransapical insertion of the elongated member. The body lumen suturingdevice further includes needles disposed within and advancable from theneedle lumens in the flexible elongated member across the elongatedsubsection to corresponding needle lumens in the barrel portion, as wellas a handle disposed at the proximal end of the elongated member, wherethe handle is operable to retract the needles through the needle lumensof the elongated member across the elongated subsection toward thehandle at the proximal end.

In yet another embodiment, a body lumen suturing device includes aflexible elongated member having a proximal end, a distal end, a centralpassage and multiple needle lumens extending from the proximal endtoward the distal end. The flexible elongated member further includes anelongated subsection spanning from the end of the needle lumens in theelongated member to a barrel portion that includes corresponding needlelumens on the proximal end of the elongated member. The elongatedsubsection provides sufficient space between the needles and the barrelportion to allow transapical insertion of the elongated member. Theelongated member also includes a crimp ring configured to hold pledgetsin place at the proximal end of the needle lumens in the elongatedmember. The device also includes needles disposed within and advancablefrom the needle lumens in the flexible elongated member across theelongated subsection to corresponding needle lumens in the barrelportion, as well as one or more pledgets stored at the proximal end ofthe needle lumens in the elongated member. The pledgets include holesthrough which the sutures may be pulled. The device also includes ahandle disposed at the proximal end of the elongated member, where thehandle is operable to retract the needles through the needle lumens ofthe elongated member across the elongated subsection toward the handleat the proximal end.

Additional features and advantages will be set forth in the descriptionwhich follows, and in part will be obvious from the description, or maybe learned by the practice of the teachings herein. Features andadvantages of the invention may be realized and obtained by means of theinstruments and combinations particularly pointed out in the appendedclaims. Features of the present invention will become more fullyapparent from the following description and appended claims, or may belearned by the practice of the invention as set forth hereinafter.

BRIEF DESCRIPTION OF THE DRAWINGS

To further clarify the above and other advantages and features ofembodiments of the present invention, a more particular description ofembodiments of the present invention will be rendered by reference tothe appended drawings. It is appreciated that these drawings depict onlytypical embodiments of the invention and are therefore not to beconsidered limiting of its scope. The invention will be described andexplained with additional specificity and detail through the use of theaccompanying drawings in which:

FIG. 1 illustrates a side view of an example embodiment of the suturingdevice.

FIG. 2 illustrates insertion of the elongate member and barrel portion.

FIG. 3 is a perspective view of an example embodiment of a suturingdevice.

FIG. 4A is a detailed view of the distal end of the guide body of thesuturing device of FIG. 2, shown with the needles retracted fully withinthe guide body.

FIG. 4B is a detailed view similar to FIG. 4A, except that the needleshave been partially deployed.

FIG. 5. is a cross-sectional view of the device of FIGS. 4A and 4B,taken along line 3-3 of FIG. 4B.

FIGS. 6A-6D illustrate various embodiments of the suturing device thatimplement pledgets.

FIG. 7 illustrates a barrel comprising semi-circular openings on thedistal end configured to draw the needles toward a narrow exit hole onthe proximal end of the barrel.

FIG. 8 illustrates the X-pattern of the tied suture applied by thesuturing device.

DETAILED DESCRIPTION

Embodiments described herein provide systems, methods, and devices forclosing an opening in tissue. Embodiments can be configured to close anopening within a body lumen. For instance, in one embodiment, anapparatus for suturing a body lumen includes a flexible elongated memberthat has a proximal end, a distal end, a central passage and multipleneedle lumens extending from the proximal end toward the distal end. Theflexible elongated member further includes an elongated subsectionspanning from the end of the needle lumens in the elongated member to abarrel portion that includes corresponding needle lumens on the proximalend of the elongated member. The elongated subsection providessufficient space between the needles and the barrel portion to allowtransapical insertion of the elongated member into a body lumen. Theapparatus further includes multiple different needles disposed withinand advancable from the needle lumens in the flexible elongated memberacross the elongated subsection to corresponding needle lumens in thebarrel portion. The apparatus also includes a handle disposed at theproximal end of the elongated member. The handle is operable to retractthe needles through the needle lumens of the elongated member across theelongated subsection toward the handle at the proximal end.

In another embodiment, a method is provided for suturing an opening in abody lumen. The method includes providing a body lumen suturing device,where the body lumen suturing device includes a flexible elongatedmember that has a proximal end, a distal end, a central passage andmultiple needle lumens extending from the proximal end toward the distalend. The flexible elongated member includes an elongated subsectionspanning from the end of the needle lumens in the elongated member to abarrel portion that includes corresponding needle lumens on the proximalend of the elongated member. The elongated subsection providessufficient space between the needles and the barrel portion to allowtransapical insertion of the elongated member. The body lumen suturingdevice further includes needles disposed within and advancable from theneedle lumens in the flexible elongated member across the elongatedsubsection to corresponding needle lumens in the barrel portion, as wellas a handle disposed at the proximal end of the elongated member, wherethe handle is operable to retract the needles through the needle lumensof the elongated member across the elongated subsection toward thehandle at the proximal end.

In yet another embodiment, a body lumen suturing device includes aflexible elongated member having a proximal end, a distal end, a centralpassage and multiple needle lumens extending from the proximal endtoward the distal end. The flexible elongated member further includes anelongated subsection spanning from the end of the needle lumens in theelongated member to a barrel portion that includes corresponding needlelumens on the proximal end of the elongated member. The elongatedsubsection provides sufficient space between the needles and the barrelportion to allow transapical insertion of the elongated member. Theelongated member also includes a crimp ring configured to hold pledgetsin place at the proximal end of the needle lumens in the elongatedmember. The device also includes needles disposed within and advancablefrom the needle lumens in the flexible elongated member across theelongated subsection to corresponding needle lumens in the barrelportion, as well as one or more pledgets stored at the proximal end ofthe needle lumens in the elongated member. The pledgets include holesthrough which the sutures may be pulled. The device also includes ahandle disposed at the proximal end of the elongated member, where thehandle is operable to retract the needles through the needle lumens ofthe elongated member across the elongated subsection toward the handleat the proximal end.

As used herein, the term “distal” is generally defined as in thedirection of the patient, or away from a user of a device, or in adownstream direction relative to a forward flow of blood. In the contextof a medical device intervention with or through a vessel wall, “distal”herein refers to the interior or the lumen side of the vessel wall.

Conversely, “proximal” generally means away from the patient, or towardthe user, or in an upstream direction relative to a forward flow ofblood. In the context of a medical device intervention with or through avessel wall, “proximal” herein refers to the exterior or outer side ofthe vessel wall.

Additionally, “oblong” is herein intended to mean oval, elliptical, orotherwise having a generally rounded shape that is not perfectlycircular. In particular, the term describes the shape of a tubular graftend cut at an acute angle relative to the plane perpendicular to thetissue walls defining the graft.

The term “hemostasis” is herein used to mean the arrest of bleeding orsubstantially blocking flow of blood outwardly from a vessel lumen whilethe vessel lumen is pressurized or sustaining physiological blood flow.This amount of blockage or occlusion to flow is further defined suchthat the blood loss which is experienced is less than an amount whichwould affect procedural methods or outcomes according to a physicianuser of a device of ordinary skill in the art. In other words,“hemostasis” is not intended to mean only “total hemostasis” such thatthere is a total lack of blood loss. Rather, the term is used to alsomean “procedural hemostasis” as a relative term in its use amongphysicians of ordinary skill.

Similarly, “occlusion,” “occlude,” “blockage,” “block . . . plugging”,“block,” or variations thereof are all terms which are herein intendedto have a procedurally relevant definition in the context of their use.For instance, an aperture is “occluded” although there is somemeasurable flow therethrough, but that flow is so low such that theintended procedural benefit of occlusion is at least partially achieved.Certainly, such terms also properly include within their scope a “totaleffect” definition, as well.

The term “perfusion” is herein used to mean the flow of blood or otherunit of perfusate (the fluid used for perfusion) per unit volume oftissue. Physiological perfusion refers to the amount of blood flowpresent when the body is functioning normally. For example,physiological perfusion usually prevents clinically significant STelevations which is one of the most sensitive indicators of inadequateperfusion. Adequate perfusion refers to the amount of blood flow thatavoids the clinical requirement of transfusing the patient or that isneeded to prevent tissue necrosis distal to the aperture in the bloodvessel.

The term “suturing” is herein intended to include the process of joiningtwo surfaces or edges together with a fastener so as to close anaperture, opening, or wound or join tissues. The fastener is usually asuture such as a thread of material (either polymeric or natural), gut,wire or the like. The term fastener as used herein also includes clamps,studs, hasps, catches, hooks, rivets, staples, snaps, stitches, VELCROC,buttons, and other coupling members.

As shown in FIG. 1, a tissue suturing device 101 may be provided toclose openings in body tissues. The tissue suturing device 101 includesmultiple different parts. These parts may be generally divided intothree sections including a handle section 192, a substantially rigidintermediate section 191, and a flexible elongated section 190. Eachsection may include different sub-parts that are each designed toprovide an intended portion of functionality.

The handle section 192 of the tissue suturing device 101 includes a handgrip 110 and rotatable handle portion 109R. The hand grip and rotatablehandle portion allow a physician or other user to hold and manipulatethe tissue suturing device 101. For example, the physician can hold onto the hand grip 110 and the rotatable handle portion 109R wheninserting or withdrawing the tissue suturing device from a body lumen.The handle section 192 also includes an actuating member 109N which ismechanically linked to the needles 115 in the elongated member 113. Whenthe handle 109N is pulled, the mechanical link to the needles isactuated and the needles are drawn from the distal end of the elongatedmember 113D toward the proximal end of the elongated member 113P. Aswill be shown further in regard to FIGS. 2 and 3, the handle 109N ismechanically linked to a support holster 121 which holds the needleswithin the sheath 105. When the handle 109N is pulled toward the user,the support holster moves, along with the needles, through the sheath105 and toward the handle.

The substantially rigid intermediate section 191 extends from therotatable handle portion 109R to the needle guide 106. This intermediatesection includes a barrel portion 108 which routes the needles 115through the barrel and out toward the handle portion 192. The needles115 carry sutures 112 which are used to close openings in the tissue.The needles extend from the needle guide 106 through any interveningtissue toward the barrel portion 108. The barrel portion captures theneedles and routes them through an opening (element 124 in FIG. 2)toward the user. The substantially rigid intermediate section 191 alsoincludes elongated subsection 107 which spans a tissue gap. This tissuegap comprises the tissue area through which the elongated subsection isinserted. The elongated subsection allows for the tissue suturing device101 to be inserted transapically into the heart or into other bodilytissues. In some embodiments, the elongated subsection 107 may allow auser to insert the device transapically and perform a percutaneousclosure of the left ventricle of the heart. This embodiment will beexplained in greater detail below.

The flexible elongated portion 190 of the tissue suturing device 101includes the needles 115 (shown in FIGS. 2-4), a guidewire port foradvancing the device along a guidewire 114 (shown in FIG. 2) and aflexible outer sheath 105. The flexible elongated portion 190 may beinserted entirely into the body lumen using the guidewire to advance thedevice. Once the tissue suturing device has been inserted into thevascular tissue, the guidewire can be removed by the operator. Thesheath 105 of the elongated member 113 supports various internalstructures including the needle holder 102. The flexibility of theelongated portion allows the elongated portion to be inserted in avariety of different types and sizes of tissues, including into arteries(such as the femoral artery) and into the heart.

The needle holder 102 of the flexible elongated portion 190 may beconfigured to hold one or more needles within needle lumens 119 whichare axially aligned and spaced about the interior of the elongatedmember 113 (as shown in FIG. 5). The needle holder, upon actuation ofthe handle 109, may be advanced up the needle shaft 111 toward theproximal end 113P of the elongated member 113. As the needle holder 102is advanced, the needles 115 held by the needle holder arecorrespondingly advanced toward the needle shaft 111 in the handle 109.The needles are withdrawn through the needle guide 106 toward the barrelportion 108. As will be explained in greater detail with regard to FIG.7, the barrel portion 108 includes two semi-circular openings 119 thatreceive the needles 115, even in cases where the needles are drawnthrough relatively large tissue gaps.

Thus, the flexible elongated portion 190 houses the needles 115 whichwill be drawn toward the handle 109 of the tissue suturing device 101.The needles 115 are withdrawn along needle guide 106 and across thetissue gap covered by elongated subsection 107 toward the barrel portion108. While being advanced from the needle guide 106 to the barrelportion 108, the needles may exhibit a tendency to deflect or travelaway from the tissue suturing device 101. For example, in cases wherethe tissue suturing device 101 is inserted transapically into the leftventricle of the heart, the tissue suturing device will be insertedthrough body tissue that is thicker and/or tougher than the body tissuetypically involved in a femoral arteriotomy. For instance, the tissuegap in a transapical insertion may be [1-5 cm]. In a femoralarteriotomy, a tissue suturing device is placed through skin and muscletissue in the leg, and ultimately through the femoral artery. In atransapical insertion, the tissue suturing device is inserted near orthrough the ribcage toward the heart. This tissue near the ribcage andheart is often fibrous and tough, and may cause the needles to deflectand travel away from the tissue suturing device. Accordingly, larger,semi-circular openings 119 are provided in the barrel portion 108 tocapture the needles 115 as they approach the handle portion 109.

Thus, to compensate for the thicker, more fibrous tissue through whichthe tissue suturing device 101 will be inserted, a tissue suturingdevice with a substantially rigid elongated subsection 107 is provided.The elongated subsection 107 provides sufficient space between theneedle guides 106 and the needle-receiving barrel portion to allowtransapical insertion of the device 101. The needles 115 are drawnthrough the tissue and across the tissue gap provided by the elongatedsubsection 107. The elongated subsection 107 is specifically designed toprovide sufficient space between the needles 115 and the barrel portion108 to allow transapical insertion of the elongated member 113. This isshow in greater detail in FIGS. 2-4. It should be noted that althoughthe tissue suturing device is usable for transapical insertion into aheart ventricle, it will be appreciated that the tissue suturing device101 can be readily adapted for use with punctures made to other hollowbody organs and lumens. It may, however, be necessary to modify thedimensions and other particular aspects of the tissue suturing device toaccommodate the different usage environments.

Referring now to FIG. 2, a tissue suturing device 101 is provided whichis suitable for suturing and sealing of a percutaneous vascular puncturesite (particularly those made transapically to the left ventricle of theheart). The tissue suturing device 101 comprises an elongated member 113and a needle shaft 111. The elongated member 113 includes a guide tip123 at its distal end. The guide tip includes a plurality of guidechannels 125 which receive the proximal ends of needles 115. The needles115, as illustrated, comprise a sharpened tip section 115A and anelongated shank portion 122, but may also be manufactured as an integralpiece. The shank portion 122 may be sufficiently long so that theneedles may be pushed from their butt end by a support holster 121fixedly attached to the needle shaft 111. By withdrawing the handle109N, the mechanically linked support holster 121 is also withdrawntoward the user, carrying the needles 115 and pushing the needlesthrough the intervening tissue. The needles may be withdrawn until theyenter the barrel portion 108 and exit through the barrel opening 124.

The elongated member 113 further includes a plurality of needle lumens119 which are axially aligned and spaced about the periphery of theelongated member. As shown in FIGS. 4B and 5, the needles 115 aredesigned to enter the distal ends of the lumens 119 as the needles areadvanced proximally relative to the elongated member 113. A flexibleneedle sheath (channel guide) 125 is attached to the guide tip 123 ofthe elongated member 113. The central lumen of the needle sheath 125receives a support holster 121 attached to the distal end of the needleshaft 111, as well as the needles 115. The butts of the needles 115 areremovably received within the support holster 121. The sheath 125 isdesigned to be sufficiently long to permit the needles to extend atleast 5 cm beyond the distal end of elongated member 113 and into thebarrel portion 108.

Prior to use, the suture applying device 101 will be in theconfiguration illustrated in FIGS. 1 and 4A. That is, the needle shaft111 will be distally positioned within the elongated member 113 andneedle sheath 125. In particular, the tips of needles 115A will lie justat the guide tip 123 so that they may be easily advanced through thevascular tissue of the heart, as well as any surrounding tissue. Thatis, the tips of the needles 115A will be generally retracted within theguide tip 123. A length of suture 112 is attached to the proximal tips115A of opposed pairs of needles 115, with the connecting suture beingstored within side lumens 126 extending axially along the exterior ofthe needle sheath 125.

As best observed in FIGS. 4A, 4B and 5, the suture 112 extending betweenone pair of opposed needles is received in a first of the side lumens126, while the suture extending between the other pair of opposedneedles is received in the second of the side lumens 126. In someembodiments, the sutures 112 may be stored in the lumens 119 of theelongated member 113 (and thus eliminate the need for side lumens 126).The use of side lumens 126 may simplify feeding of the suture as theneedles 115 are withdrawn.

After the guide tip 123 has been passed through the puncture site to besutured, the needles may then be drawn proximally forward through thetissue to be sutured by drawing proximally on handle 109 at the proximalend of needle shaft 111. Methods described herein for suturing anopening in a body lumen will now be described in more detail withreference to FIGS. 2-4.

The situation following an interventional or other vascular procedure,where the attending physician is satisfied that the puncture site may besealed, is illustrated in FIG. 2. The device 101 may then be introducedover a guidewire 114, as illustrated in FIG. 2. The needles 115 andsutures 112 mostly encased by flexible needle sheath 105, will be fullyadvanced into the artery or ventricle FA past the puncture site A. Thehandle 109N may then be partially withdrawn proximally to expose theneedle lumens 119 (as shown in FIGS. 1, 4A and 4B).

The handle 109N will then be drawn proximally outward relative to theelongated member 113, causing the needles 115 to pass through thesuperficial wall of the artery/ventricle FA and into the needle lumens119, as illustrated in FIGS. 2 and 4B. The handle 109 may continue to bedrawn proximally (i.e., outward from the patient) in order to continueto pull the needle shaft 111 through the elongated member 113. Suchmovement of the needle shaft 111, in turn, continues to draw the needles115 outward through the lumens 119 of the elongated member 113 until thetips of the needles are exposed.

As mentioned above, the needles 115 are drawn from out of needle lumens119 and through any intervening tissue. The tissue may be thick andfibrous, as is the case when the tissue suturing device is insertedtransapically into the heart. The device's elongated subsection 107provides sufficient rigidity and stiffness for insertion through andplacement in the thick and fibrous tissue. It is across this elongatedsubsection 107 and through this tissue that the needles 115 arewithdrawn. In some cases, the needles 115 may deflect or drift whiletraveling through this tissue. Upon reaching the outer surface of thetissue, the needles may be guided into the semicircular openings of thebarrel portion 108. The needles will thus carry their attached sutures112 through the tissue, across the elongated subsection 107, and throughthe barrel portion 108. The sutures can then be grasped by the user anddrawn out until the sutures are available to the user. The elongatedmember 113 may then be withdrawn from the support sheath 105, leaving aportion of the needle sheath 125 still in the puncture site A tomaintain hemostasis. The suture can then be tied and the knot pushedback down to the puncture site A. The knot will then only be tightenedwhen the needle sheath is finally withdrawn from the puncture site A.

It can be seen that the guide tip 123 deflects the needles radiallyoutward so that the pattern of four needles engages the arterial orventrical wall in an approximately square pattern. These needles arethen captured by the barrel portion 108. As shown in FIG. 7, the barrelportion captures the needles 115 traveling toward the handle 109. Theneedles 115 enter the distal end of the barrel portion 108 through oneof two semi-circular openings 119 (in some cases, there may be more orfewer openings, and the openings may be in shapes other thansemi-circles). The outer surface at the proximal end of the barrelportion 108 includes a hole 124 connected to the semi-circular openings119 through which the needles 115 are withdrawn. As such, the openings119 direct the needles on a narrower trajectory toward the handle 109 ofthe suturing apparatus. The needles are drawn across the elongatedsubsection 107 in order to reach the barrel portion 108. The elongatedsubsection 107 may be a predefined length, and may be specificallydesigned for the tissue though which the elongated member 113 is to beinserted.

For instance, as mentioned above, when the suturing device 101 istransapically inserted into the left ventricle of the heart, theelongated subsection 107 may comprise a specific length (e.g. within therange of [1-5 cm]) for that type and/or thickness of tissue. Other typesof insertion may necessitate use of a longer or shorter elongatedsubsection 107. In some cases, the diameter of the barrel portion 108may be proportional to the thickness of the tissue (i.e. the tissuegap). Thus, in cases where the tissue gap is longer (e.g. within therange of [4-5 cm]) and the needles are more prone to drift, the barrelportion 108 may be larger. Conversely, in cases where the tissue gap isshorter (e.g. within the range of [1-2 cm]) and the needles are lessprone to drift, the barrel portion 108 may be smaller in diameter.

In specific cases where the body lumen suturing device is inserted intothe left ventricle of the heart transapically, and implemented to suturean opening in the left ventricle of the heart, the elongated portion 113of the suturing apparatus 101 may be advanced through the body lumenopening so that the needle lumens 106 are entirely within the body lumen150. The elongated member 113 of suturing apparatus 101 may be advancedin this manner until it is substantially aligned with the interior wallof the body lumen. One or more pledgets 116 stored at the proximal endof the needle lumens 106 in the elongated member 113 may be placedbetween the needle ends and the interior wall of the body lumen (asshown in FIG. 6C). The needles 115A/115B and attached sutures 114A/114Bare withdrawn through holes 118 in the pledget(s) 116. As such, thepledgets remain in contact with the interior wall of the body lumen 150,protecting the interior wall from forces applied to the sutures. Thehandle 109 may then be actuated to withdraw the needles 115 carrying thesutures 112 along the needle lumens 106, through the interior wall ofthe body lumen 150, and out through the opening 124 of the barrelportion 108. After the sutures are tied and the knots advanced backthrough the support sheath 105, the resulting pattern of tied suturewill appear as in FIG. 8 when viewed towards adventitial surface of thebody.

Turning now to another embodiment, the tissue suturing apparatus 101 mayfurther be designed to implement pledgets. As used herein, a pledget mayrefer to an absorbent pad or other cloth- or cotton-like material forabsorbing bodily fluids. In some cases, the pledgets may be fabricatedusing biocompatible and/or absorbable materials, and may be usedaccordingly in different applications. For instance, pledgets may beplaced interior to or exterior to a body lumen. Accordingly, a pledgetmay be placed inside an arterial wall, outside an arterial wall, orelsewhere in the body. In embodiments where pledgets are used inventricles of the heart, the pledgets may protect the inner ventriclefrom cutting of the tissue by knot advancement, tying or by othercauses. The pledgets may be stored at the end of the proximal end of theneedle lumens 106. The sutures 114A/114B may be routed through holes thepledgets. These holes are large enough not to restrict suture travel.The pledgets may be held in place by crimp ring 104. These concepts willbe explained below with regard to FIGS. 6A-6D.

FIG. 6A illustrates a zoomed-in view of the proximal end of the needlelumens 106, and the distal end of the elongated subsection 107. Needles115A and 115B are shown still within the sheath 105 of the elongatedmember 113. Corresponding sutures 114A and 114B are attached to needles115A and 115B. In some cases, the sutures may be of differing colors.For instance, suture 114A may be colored green, while suture 114B iscolored white. The sutures may be drawn through a hole 118 in pledget116. The pledget may be held in place by crimp ring 104 which extendsaround the elongated member 113.

As mentioned previously, the pledgets may be used both interior to andexterior to a vascular or arterial wall. Accordingly, FIG. 6Billustrates an embodiment where the pledget 116 is placed on theinterior side of a body lumen (e.g. tissue 150). The sutures arethreaded through the hole 118 in the pledget, and then through thetissue 150 as they are drawn toward the barrel portion 108 of thesuturing apparatus. In this position, the pledget can alleviate bleedingin the vascular wall, and help to maintain hemostasis. Although shownwith four needles 115 and two sutures, it should be noted thatsubstantially any number of needles and/or sutures may be used indifferent scenarios. In some cases, it may be beneficial to have more orfewer needles and/or sutures. Accordingly, the suturing apparatus may beadapted (or remanufactured) to be used in these cases.

Thus, as shown in FIG. 6C, the sutures 114A/114B held by the needles 115are threaded through the pledget 116, which is located between thesutures and the interior wall of the body lumen 150. In some cases, asshown in FIG. 6D, a second, different pledget may be placed in additionto (or as an alternative to) the pledget placed on the interior side ofthe body lumen (pledget 116B). Pledget 116A may be placed on the outsideof the body lumen, and may function to alleviate bleeding on the outerpart of the vascular wall. The exterior pledget (116A) may, like theinterior pledget 116B, be threaded with sutures 114A and 114B. Thesesutures may be drawn through the pledget(s) and out through the puncturesite (PS). Thus, in FIG. 6D, the sutures 114A/114B held by the needles115 are threaded through the interior pledget 116B within the bodylumen. The sutures 114A/114B are also threaded through the exteriorpledget 116A which is exterior to the body lumen 150, such that theexterior pledget 116A is located between the exterior wall of the bodylumen and the barrel portion 108 of the apparatus 101. The pledgets arestored at the proximal end 113P of the needle lumens 106 in theelongated member 113, and are held in place by a crimp ring 104configured to hold the pledgets in place at the proximal end of theneedle lumens 106 in the elongated member until they are withdrawn alongwith the sutures and the needles toward the barrel portion 108.

A pledget 116 includes slits in various locations. The slits may beplaced on the outer edge of the pledget in order to allow a suture to beslid into place (as opposed to being threaded through a hole in thepledget). The pledget may have two slits on opposite sides. Each slitmay have two sutures through it. Substantially any number of suturesand/or slits may be used. The sutures may be slid through the slits andwrapped underneath the pledget. The ends of the sutures 112A and 112Bmay come out of the top surface of the pledget. The pledget slits may besewn or otherwise fastened shut, resulting in sewn edges. The edges maybe sewn after the sutures have been slid into place. The slits thusallow the sutures to be slid into place on the pledget, while the sewnedges prevent the sutures from coming out of place.

These slits and sewn edges may be configured in different arrangements.A pledget 116 may include crossing sutures 112A and 112B. The suturesmay be slid into place using the respective slits. The sutures mayextend out of the slits toward the user and/or toward the tissuesuturing device. The sutures may be held in place within the slits withthe sewn edges. As with the pledgets described above, the pledgets canbe held in place in the tissue suturing device 101 using crimp ring 104.Or, alternatively, the pledgets can be held in place by the suturesthemselves. For example, if the sutures are crossed behind the suture,the pledget may be drawn up next to the tissue suturing device with thesutures holding the pledget in place. The sutures may be slid into placethrough slits, and may be aligned next to each other vertically. The topends of the sutures 112A and 112B are then available for the user ordevice.

Accordingly, methods, systems and apparatuses are provided for suturingbody lumens. A predefined tissue gap may be implemented to providemechanisms for inserting the suturing device transapically into the leftventricle of the heart. Moreover, pledgets may be positioned within thesuturing device for implementation on the exterior and interior walls ofthe body lumen. The placement of these pledgets may reduce blood lossand may assist in maintaining hemostasis.

The present invention may be embodied in other specific forms withoutdeparting from its spirit or essential characteristics. The describedembodiments are to be considered in all respects only as illustrativeand not restrictive. The scope of the invention is, therefore, indicatedby the appended claims rather than by the foregoing description. Allchanges which come within the meaning and range of equivalency of theclaims are to be embraced within their scope.

1. An apparatus for suturing a body lumen, the apparatus comprising: aflexible elongated member having a proximal end, a distal end, a centralpassage and a plurality of needle lumens extending from the proximal endtoward the distal end, wherein the flexible elongated member comprisesan elongated subsection spanning from the end of the needle lumens inthe elongated member to a barrel portion comprising corresponding needlelumens on the proximal end of the elongated member, the elongatedsubsection providing sufficient space between the needles and the barrelportion to allow transapical insertion of the elongated member; aplurality of needles disposed within and advancable from the pluralityof needle lumens in the flexible elongated member across the elongatedsubsection to one or more corresponding needle lumens in the barrelportion; and a handle disposed at the proximal end of the elongatedmember, the handle being operable to retract one or more of theplurality of needles through the needle lumens of the elongated memberacross the elongated subsection toward the handle at the proximal end.2. The apparatus of claim 1, further comprising a first pledget.
 3. Theapparatus of claim 2, wherein the first pledget is located within thebody lumen.
 4. The apparatus of claim 3, wherein sutures held by theneedles are threaded through the first pledget, wherein the firstpledget is located between the suture and the interior wall of the bodylumen.
 5. The apparatus of claim 4, further comprising a second pledgetlocated exterior to the body lumen.
 6. The apparatus of claim 5, whereinsutures held by the needles are threaded through the first pledgetwithin the body lumen, wherein the first pledget is located between thesuture and the interior wall of the body lumen, and wherein the suturesare further threaded through the second pledget exterior to the bodylumen, wherein the second pledget is located between the exterior wallof the body lumen and the barrel portion of the apparatus.
 7. Theapparatus of claim 4, wherein the pledgets are stored at the proximalend of the needle lumens in the elongated member.
 8. The apparatus ofclaim 7, wherein the elongated member comprises a crimp ring configuredto hold the pledgets in place at the proximal end of the needle lumensin the elongated member.
 9. The apparatus of claim 4, wherein at leastone of the pledgets includes slits on one or more outer edges of thepledget through which the sutures are each pulled into appropriatepositions on the pledget.
 10. The apparatus of claim 9, wherein one ormore of the pledget slits are sewn together on the outer edge of theslit.
 11. The apparatus of claim 10, wherein the sewn edge of thepledget slit prevents the sutures from sliding out of the pledget. 12.The apparatus of claim 1, wherein the elongated subsection spans apredefined tissue gap length.
 13. The apparatus of claim 7, wherein thediameter of the barrel portion is proportional to the tissue gap.
 14. Amethod for suturing an opening in a body lumen, the body lumen beingaccessed in a transapical manner, the method comprising: providing abody lumen suturing device, the body lumen suturing device comprising aflexible elongated member having a proximal end, a distal end, a centralpassage and a plurality of needle lumens extending from the proximal endtoward the distal end, wherein the flexible elongated member comprisesan elongated subsection spanning from the end of the needle lumens inthe elongated member to a barrel portion comprising corresponding needlelumens on the proximal end of the elongated member, the elongatedsubsection providing sufficient space between the needles and the barrelportion to allow transapical insertion of the elongated member, the bodylumen suturing device further comprising a plurality of needles disposedwithin and advancable from the plurality of needle lumens in theflexible elongated member across the elongated subsection to one or morecorresponding needle lumens in the barrel portion and a handle disposedat the proximal end of the elongated member, the handle being operableto retract one or more of the plurality of needles through the needlelumens of the elongated member across the elongated subsection towardthe handle at the proximal end; advancing the elongated member throughthe body lumen opening such that the needle lumens are entirely withinthe body lumen and the elongated subsection is substantially alignedwith the interior wall of the body lumen; and actuating the handle towithdraw the needles carrying the sutures along the needle lumens of theelongate member, through the interior wall of the body lumen and acrossthe elongated subsection, and out through the corresponding needlelumens in the barrel portion.
 15. The method of claim 14, wherein thebody lumen suturing device is inserted into the left ventricle of theheart transapically, and implemented to suture an opening in the leftventricle of the heart.
 16. The method of claim 15, wherein one or morepledgets stored at the proximal end of the needle lumens in theelongated member are placed between the needle ends and the interiorwall of the body lumen.
 17. The method of claim 16, wherein the needlesand attached sutures are withdrawn through holes in the pledgets, suchthat the pledgets remain in contact with the interior wall of the bodylumen, protecting the interior wall from forces applied to the sutures.18. A body lumen suturing device comprising the following: a flexibleelongated member having a proximal end, a distal end, a central passageand a plurality of needle lumens extending from the proximal end towardthe distal end, wherein the flexible elongated member comprises anelongated subsection spanning from the end of the needle lumens in theelongated member to a barrel portion comprising corresponding needlelumens on the proximal end of the elongated member, the elongatedsubsection providing sufficient space between the needles and the barrelportion to allow transapical insertion of the elongated member, whereinthe elongated member comprises a crimp ring configured to hold pledgetsin place at the proximal end of the needle lumens in the elongatedmember; a plurality of needles disposed within and advancable from theplurality of needle lumens in the flexible elongated member across theelongated subsection to one or more corresponding needle lumens in thebarrel portion; one or more pledgets stored at the proximal end of theneedle lumens in the elongated member, wherein the pledgets include oneor more holes through which the sutures are pulled; and a handledisposed at the proximal end of the elongated member, the handle beingoperable to retract one or more of the plurality of needles through theneedle lumens of the elongated member across the elongated subsectiontoward the handle at the proximal end.
 19. The body lumen suturingdevice of claim 18, wherein the barrel portion comprises a distal endand a proximal end, the distal end comprising one or more semi-circularopenings through which the needles from the proximal end of theelongated member are routed.
 20. The body lumen suturing device of claim19, wherein the outer surface at the proximal end of the barrel portioncomprises a hole connected to the semi-circular openings through whichthe routed needles are withdrawn.